SOLIFENACIN SUCCINATE

Posology Adults, including the elderly The recommended dose is 5 mg solifenacin succinate once daily. If needed, the dose may be increased to 10 mg solifenacin succinate once daily. Paediatric population The safety and efficacy of solifenacin in children have not yet been established.

Therefore, solifenacin should not be used in children. Patients with renal impairment No dose adjustment is necessary for patients with mild to moderate renal impairment (creatinine clearance > 30 ml/min). 2). Patients with hepatic impairment No dose adjustment is necessary for patients with mild hepatic impairment.

2). g. 5). Method of administration Solifenacin should be taken orally and should be swallowed whole with liquids. It can be taken with or without food.

Summary of the safety profile Due to its pharmacological effect, solifenacin may cause anticholinergic undesirable effects of (in general) mild or moderate severity. The frequency of anticholinergic undesirable effects is dose related.

The most commonly reported adverse reaction with solifenacin was dry mouth. It occurred in 11% of patients treated with 5 mg once daily, in 22% of patients treated with 10 mg once daily and in 4% of placebo-treated patients. The severity of dry mouth was generally mild and did only occasionally lead to discontinuation of treatment.

In general, medicinal product compliance was very high (approximately 99%) and approximately 90% of the patients treated with solifenacin completed the full study period of 12 weeks treatment. Tabulated list of adverse reactions The following table summarises adverse drug reactions of solifenacin divided into groups according to MedDRA terminology together with their frequency: very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1,000 to < 1/100); rare (≥ 1/10,000 to < 1/1,000); very rare (< 1/10,000), not known (cannot be estimated from the available data).

MedDRA system organ class Frequency Undesirable effect Infections and infestations Uncommon Urinary tract infection Cystitis • Immune system disorders Not known Anaphylactic reaction* • Metabolism and nutrition disorders Not known Decreased appetite* Hyperkalaemia* Very rare Hallucinations* Confusional state* • Psychiatric disorders Not known Delirium* Uncommon Somnolence Dysgeusia • Nervous system disorders Rare Dizziness* Headache* Common Blurred vision• Eye disorders Uncommon Dry eyes Not known Glaucoma* • Cardiac disorders Not known Torsade de Pointes* Electrocardiogram QT prolonged* Atrial fibrillation* Palpitations* Tachycardia* Uncommon Nasal dryness• Respiratory, thoracic and mediastinal disorders Not known Dysphonia* Very common Dry mouth Common Constipation Nausea Dyspepsia Abdominal pain Uncommon Gastro-oesophageal reflux diseases Dry throat Rare Colonic obstruction Faecal impaction Vomiting* • Gastrointestinal disorders Not known Ileus* Abdominal discomfort* • Hepatobiliary disorders Not known Liver disorder* Liver function test abnormal* Uncommon Dry skin Rare Pruritus* Rash* Very rare Erythema multiforme* Urticaria* Angio-edema* • Skin and subcutaneous tissue disorders Not known Exfoliative dermatitis* • Musculoskeletal and connective tissue disorders Not known Muscular weakness* Uncommon Difficulty in micturition• Renal and urinary disorders Rare Urinary retention Not known Renal impairment* • General disorders and administration site conditions Uncommon Fatigue Peripheral oedema * Observed post-marketing.

Other causes of frequent urination (heart failure or renal disease) should be assessed before treatment with Solifenacin. If urinary tract infection is present, an appropriate antibacterial therapy should be started. Solifenacin should be used with caution in patients with − clinically significant bladder outflow obstruction at risk of urinary retention.

− gastrointestinal obstructive disorders. − risk of decreased gastrointestinal motility. 2) and doses should not exceed 5 mg for these patients. 2) and doses should not exceed 5 mg for these patients. g. 5). − hiatus hernia/gastro-oesophageal reflux and/or who are concurrently taking medicinal products (such as bisphosphonates) that can cause or exacerbate oesophagitis.

− autonomic neuropathy. QT prolongation and Torsade de Pointes have been observed in patients with risk factors, such as pre-existing long QT syndrome and hypokalaemia. Safety and efficacy have not yet been established in patients with a neurogenic cause for detrusor overactivity.

Angio-edema with airway obstruction has been reported in some patients on solifenacin succinate. If angio-edema occurs, solifenacin succinate should be discontinued and appropriate therapy and/or measures should be taken. Anaphylactic reaction has been reported in some patients treated with solifenacin succinate.

In patients who develop anaphylactic reactions, solifenacin succinate should be discontinued and appropriate therapy and/or measures should be taken. The maximum effect of Solifenacin can be determined after 4 weeks at the earliest.

The product contains lactose monohydrate. Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption should not take this medicine.

1. − with urinary retention, severe gastro-intestinal condition (including toxic megacolon), myasthenia gravis or narrow-angle glaucoma and in patients at risk for these conditions. 2). 2). g. 5).